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Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms
Open accessAbstract
BACKGROUND: Mineralocorticoid antagonists improve survival among patients with chronic, severe systolic heart failure and heart failure after myocardial infarction. We evaluated the effects of eplerenone in patients with chronic systolic heart failure and mild symptoms. METHODS: In this randomized, double-blind trial, we randomly assigned 2737 patients with New York Heart Association class II heart failure and an ejection fraction of no more than 35% to receive eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure. RESULTS: The trial was stopped prematurely, according to prespecified rules, after a median follow-up period of 21 months. The primary outcome occurred in 18.3% of patients in the eplerenone group as compared with 25.9% in the placebo group (hazard ratio, 0.63; 95% confidence interval [CI], 0.54 to 0.74; P<0.001). A total of 12.5% of patients receiving eplerenone and 15.5% of those receiving placebo died (hazard ratio, 0.76; 95% CI, 0.62 to 0.93; P=0.008); 10.8% and 13.5%, respectively, died of cardiovascular causes (hazard ratio, 0.76; 95% CI, 0.61 to 0.94; P=0.01). Hospitalizations for heart failure and for any cause were also reduced with eplerenone. A serum potassium level exceeding 5.5 mmol per liter occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001). CONCLUSIONS: Eplerenone, as compared with placebo, reduced both the risk of death and the risk of hospitalization among patients with systolic heart failure and mild symptoms. (Funded by Pfizer; ClinicalTrials.gov number, NCT00232180.).
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“This effect was independent of diabetes status, and baseline HbA1c did not modify the effects on the primary outcome.531”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [531]
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“The mortality benefit of spironolactone in the RALES trial and eplerenone in the EMPHASIS-HF trial was consistent in T2DM and non-T2DM patients with HFrEF.158,159”
From Type 2 diabetes mellitus and heart failure: A position statement from the Heart Failure Association of the European Society of Cardiology (2018) · cites this paper as [159]
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Self-citation
Metadata
- Authors
- Zannad, F., McMurray, J. J. V., Krum, H., van Veldhuisen, D. J., Swedberg, K., Shi, H., Vincent, J., Pocock, S. J., & Pitt, B.
- Affiliations
- Inserm (FR)
- Monash University (AU)
- University of Gothenburg (SE)
- Pfizer (United States) (US)
- London School of Hygiene & Tropical Medicine (GB)
- University of Michigan (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-01-06
- Volume
- 364
- Issue
- 1
- Pages
- 11-21
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2164705414
- Cited by
- 3,111
- References
- 27
- Citations by year
- 2026: 184 · 2025: 168 · 2024: 167 · 2023: 177 · 2022: 228 · 2021: 197 · 2020: 190 · 2019: 181 · 2018: 178 · 2017: 177 · 2016: 187 · 2015: 227 · 2014: 209 · 2013: 239 · 2012: 216
- FWCI
- 139.30
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Research Bank (Australian Catholic University) (submittedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Fibrosis and Remodeling
- Keywords
- eplerenone, mineralocorticoid receptor antagonists, heart failure with reduced ejection fraction, mild symptoms, heart failure hospitalization, cardiovascular mortality, hyperkalemia, ejection fraction
- MeSH terms
- Eplerenone, Aged, Mineralocorticoid Receptor Antagonists, Cardiovascular Agents, Cardiovascular Diseases, Combined Modality Therapy, Double-Blind Method, Female, Follow-Up Studies, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Spironolactone, Proportional Hazards Models, Defibrillators, Implantable, Kaplan-Meier Estimate
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